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Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01202240
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE September 15, 2010
Last Update Posted Date February 17, 2011
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
AUCinf of tasocitinib (CP-690,550) [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • AUClast, Cmax, and Tmax of tasocitinib (CP-690,550) [ Time Frame: 5 days ]
  • Safety: laboratory tests, AE reporting and vital signs [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Official Title  ICMJE A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Tasocitinib (CP-690,550) In Healthy Volunteers
Brief Summary Estimate the effect of oral ketoconazole administration (400 mg once daily over 3 days) on the pharmacokinetics (process by which the drug is absorbed, distributed, metabolized, and eliminated by the body) of single 10 mg dose of tasocitinib (CP-690,550) in normal healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Tasocitinib (CP-690,55) plus Ketoconazole
Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)
Study Arms  ICMJE Experimental: Tasocitinib (CP-690,550) plus Ketoconazole
Intervention: Drug: Tasocitinib (CP-690,55) plus Ketoconazole
Publications * Gupta P, Chow V, Wang R, Kaplan I, Chan G, Alvey C, Ni G, Ndongo MN, LaBadie RR, Krishnaswami S. Evaluation of the effect of fluconazole and ketoconazole on the pharmacokinetics of tofacitinib in healthy adult subjects. Clin Pharmacol Drug Dev. 2014 Jan;3(1):72-7. doi: 10.1002/cpdd.71. Epub 2013 Oct 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Clinically significant disease
  • Recent history of serious infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01202240
Other Study ID Numbers  ICMJE A3921054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP